Kornimate/medical-research-clean huggingface dataset:
gas usage for those with copd who experience low oxygen levels during activities only

Conditions: Chronic Obstructive Pulmonary Disease

Summary: several studies have described the use of supplemental oxygen during exertion or activities of daily living (ambulatory oxygen) in study populations that have different characteristics. this report, based on specialized randomized controlled trials, characterizes ambulatory gas usage among patients with copd who experience low oxygen levels during activities.


Eligibility criteria:
inclusion criteria: * diagnosis of copd * dyspnea limiting daily activities * desaturation less than or equal to 88% for 2 continuous minutes during a room air six-minute walk test exclusion criteria: * less than or equal to 18 years old * those who met criteria for mortality reduction with long-term oxygen * those who received oxygen for palliative care or isolated nocturnal hypoxemia * those unable to complete the questionnaires or provide informed consent

Keywords: ambulatory oxygen therapy copd exertional hypoxemia
measurement of noradrenaline concentrations using different dilution methods

Conditions: Arterial Hypertension

Summary: norepinephrine is the vasopressor of choice for the treatment of peri-anesthetic arterial hypotension. the use of this drug at significantly lower concentrations (dilution factor between 40 and 200) than the commercial preparation is increasingly common in the operating room ("baby-noradrenaline"). in addition, dilution errors are potentially serious for the patient (hypertensive peak) the preparation of precise dilutions is an important factor for the safe use of this medically in this study, the investigators wish to compare the dilution method of the protocol with another method of preparation (left to the free choice of the participant).


Eligibility criteria:
inclusion criteria: * adult person, * employee of strasbourg university hospitals, * likely to have to prepare anesthesia drugs in the operating room (intern, hospital student, iade, iade student) exclusion criteria: - subject's refusal to participate in the study

Keywords: noradrenaline norepinephrine concentration of noradrenaline vasopressor baby-noradrenaline dilution of noradrenaline
ipt for major depression following perinatal loss: healing after loss (heal)

Conditions: Major Depressive Disorder

Summary: this study tests the efficacy of interpersonal psychotherapy (ipt) for major depression following perinatal loss (early and late fetal death and early neonatal death) in a sample of 274 women in flint and detroit, michigan. the trial will be the first fully powered randomized trial of treatment for any psychiatric disorder following perinatal loss.

the goal of this study is to conduct a fully-powered randomized efficacy study of ipt for mdd following perinatal loss. our perinatal-loss adapted group ipt will be compared to a standard depression intervention (cwd, also delivered in a group format) in a sample of 274 women experiencing mdd following perinatal loss. the proposed randomized controlled trial (rct) will test the hypotheses that: (1) ipt for perinatal loss will result in reduced time to recovery from mdd (primary), depressive symptoms, and ptsd symptoms (secondary) relative to cwd; and that among women meeting criteria for ptsd, ipt will result in reduced time to recovery from ptsd; (2) ipt for perinatal loss will result in increased social support, social role functioning (including parental functioning for women with living children), and well-being, and decreased grief and fear of subsequent pregnancies, relative to cwd; and (3) social support and grief will mediate the effects of ipt on time to mdd recovery.

Eligibility criteria:
inclusion criteria: * women who meet current diagnostic and statistical manual 5 (dsm-5) criteria for major depressive disorder (mdd) * have experienced a perinatal loss (including early and late fetal death, death of a liveborn neonate within the first 28 days, and medically recommended termination) within the last 1-12 months * are 18 to 50 years old * speak and understand english well enough to understand questionnaires when they are read aloud * can provide the name and contact information of at least two locator persons * have access to a telephone through owning one, a relative/friend, or an agency exclusion criteria: * onset of current major depressive episode prior to news of difficulties with the pregnancy or health risk to the infant (women with prior episodes will be included) * current or past diagnosis of bipolar disorder, schizophrenia or other psychotic disorder * primary diagnosis of current substance use disorder * acute suicidal or homicidal risk * non-stable course of antidepressant medication or psychotherapy (i.e., beginning or changing dose of either within the previous 12 weeks) * any ipt or cognitive-behavioral treatment in the previous 12 weeks

Keywords: perinatal loss depression
a study of rdea806 in hyperuricemic subjects with symptomatic gout

Conditions: Hyperuricemia

Summary: the purpose of this study is to determine whether rdea806 is effective in the treatment of hyperuricemia in gout patients.


Eligibility criteria:
inclusion criteria: * patient is hyperuricemic: screening serum uric acid ≥8 mg/dl. * patient meets one or more of the 1977 ara criteria for the diagnosis of gout. * patient is willing and able to give informed consent and adhere to visit/protocol schedules * all female subjects of child-bearing potential must agree to use a barrier method of birth control (e.g. condom, diaphragm or cap). exclusion criteria: * consumes more than 14 drinks of alcohol per week. * history or suspicion of drug abuse. * history of kidney stones, rheumatoid arthritis or other autoimmune disease, significant cardiac dysfunction. * diabetes mellitus requiring treatment * confirmed or suspected hiv-1 infection. * malignancy, except treated non-melanomatous skin cancer and cervical dysplasia. * uncontrolled hypertension. * inadequate renal function. * hemoglobin \< 8 g/dl (males) or \< 7 g/dl (females). * alt, ast , or ggt 2 x uln * active peptic ulcer disease. * requires long-term use of salicylates; thiazide diuretics; losartan; azathioprine; mercaptopurine; theophylline; iv colchicine; cyclosporine; cyclophosphamide; pyrazinamide; sulfamethoxazole; trimethoprim. * pregnant or breast feeding. * use of an investigational drug within 4 weeks prior to study drug administration. * known hypersensitivity or allergy to rdea806 or colchicine or any components in their formulations. * any other medical or psychological condition which, in the opinion of the investigator, might create undue risk to the subject or interfere with the subject's ability to comply with the protocol requirements, or to complete the study. * history of cardiac abnormalities including abnormal and clinically relevant ecg changes. * conditions predisposing to qt prolongation. * any use of concomitant medications that prolong the qt/qtc interval within 14 days prior to day 1. * subjects with a qtcf interval \>450 milliseconds at screening or on day -1 or at pre-dose (hour 0) on day 1.
the effect of dual task on upper extremity functions in multiple sclerosis patients

Conditions: Multiple Sclerosis

Summary: the primary aim of this study was to investigate the effect of dual tasking on upper extremity functions in individuals with multiple sclerosis (ms) and compare with healthy controls. additionally, another aim of our study was to compare the cognitive status, quality of life, fatigue and emotional states of individuals with ms and healthy controls.

the study was carried out at kutahya health sciences university evliya çelebi training and research hospital. 30 individuals with ms and 30 healthy controls, aged 18-65, were included in the study. in the evaluation, demographic and clinical data were recorded first. the minnesota manual dexterity test was used to evaluate the upper extremity function of the participants in single and dual task conditions, and the dual task questionnaire was used to evaluate the difficulties experienced during dual tasks.

Eligibility criteria:
inclusion criteria: * having been diagnosed with multiple sclerosis for at least 1 year * being between the ages of 18-65 * being at least a primary school graduate * volunteering to participate in the study * edss score between 1 and 6.5 exclusion criteria: * patients whose multiple sclerosis diagnosis is uncertain * having additional neurological disease that may affect clinical evaluation * having a neurological and/or psychiatric disease that may affect cognitive tests * having had an attack in the last 3 months

Keywords: dual task dual task effect multiple sclerosis upper extremity
curative effect and mechanism of transcutaneous auricular vagus nerve stimulation on sleep disorders of pd

Conditions: Parkinson Disease

Summary: this study is a double-blind comparative study examining the curative effect and mechanism of the transcutaneous auricular vagus nerve stimulation treatment on non-motor symptoms of parkinson's disease patients. the investigators hypothesize that treatment using transcutaneous auricular vagus nerve stimulation will improve the non-motor symptoms, such as improving sleep, and improve cortical activity simultaneously in parkinson's disease patients.

patients in the experimental group underwent fourteen consecutive daily sessions of transcutaneous auricular vagus nerve stimulation (tavns, twice daily, 30 minutes each time), whereas patients in the sham stimulation group underwent fourteen consecutive daily sessions of sham tavns. assessments of motor and non-motor symptoms, cortical activity (using functional near-infrared spectroscopy) and blood indicators were performed three times: at baseline, one day post intervention, fourteen days post intervention.

Eligibility criteria:
inclusion criteria: (i) right-handed individuals aged 45-80 years; (ii) met the diagnostic criteria for idiopathic pd and had been stable on medication for at least one month; (iii) met the diagnostic criteria for insomnia according to the diagnostic and statistical manual of mental disorders, fourth edition, and insomnia had to have lasted for at least six months, with pittsburgh sleep quality index (psqi) scores \>7; (iv) no history of medication that might affect the study, such as sleeping pills or antidepressants, that is, the psqi hypnotic medication score of 0; (v) clear consciousness, basic communication skills and cooperation in all assessments and treatments; (vi) the patients agreed to participate in the study and signed an informed consent form. exclusion criteria: (i) those with concomitant cognitive dysfunction, such as montreal cognitive assessment (moca) \<23; (ii) those with secondary parkinson's syndrome or parkinson's superimposed syndrome; (iii) those with severe cardiac, pulmonary, hepatic, renal, or concomitant malignancies or a history of previous brain surgery; (iv) those with contraindications to tavns interventions; (v) those with severe psychiatric disorders; (vi) insomnia not caused by pd, such as frequent (two times per week) nighttime use of sedative medications (including sedative antidepressants), untreated restless legs syndrome, night-shift work or other occupations that result in abnormal sleep patterns, insomnia associated with dopamine therapy, and other reversible causes of insomnia identified by the baseline clinical interview.

Keywords: non-motor symptoms therapeutics nighttime insomnia
dosing study of the effects of nebivolol on blood pressure in black patients with mild to moderate hypertension

Conditions: Hypertension

Summary: the purpose of this study was to determine if nebivolol is superior to placebo for the treatment of elevated blood pressure in black patients with mild to moderate hypertension.

this study was a phase ii, 12-week multicenter, randomized, double-blind, parallel group, placebo-controlled study of nebivolol over a range of doses in black patients with mild to moderate hypertension. treatment was administered once daily (qd) for 12 weeks. the study consisted of 2 phases: (1) screening/washout/single-blind placebo run-in and (2) randomization/treatment. patients had 7 scheduled clinic visits during the study (6 clinic visits for patients not on current antihypertensive medication).

Eligibility criteria:
inclusion criteria: * black adults with an average sitting diastolic blood pressure of greater then or equal to 95 mmhg and less then or equal to 109 mmhg at baseline. exclusion criteria: * recent myocardial infarction or stroke * contraindication to beta-blocker therapy

Keywords: nebivolol beta-blocker
comparison between hd+ endoscopy and standard videoendoscopy in screening colonoscopy

Conditions: Polyps; Neoplasia

Summary: colonoscopy is the accepted gold standard for screening of colorectal cancer. however, small and flat neoplastic lesions might be overlooked with standard video endoscopes. the new available epki system (pentax, japan) enables with hd+ imaging resolution above hdtv standard. aim of the study was to test the efficacy of hd+ colonoscopy alone and in conjunction with i-scan (newly developed post processing digital filter)in comparison to standard videoendoscopy


Eligibility criteria:
inclusion criteria: * consecutive patients scheduled for screening colonoscopy exclusion criteria: * inflammatory bowel disease * cancer * pregnancy * inability to obtain informed consent * prothrombin time \< 50% of control * partial thromboplastin time \> 50 seconds
study on mannan binding lectin (mbl) substitution in mbl-deficient children with chemotherapy-induced neutropenia

Conditions: MBL-Deficient; Neutropenia

Summary: the pharmacokinetics, and clinical and biological effects of mbl replacement therapy in mbl-deficient children during chemotherapy-induced neutropenia were studied.

mannan binding lectin (mbl) is a member of the lectin pathway of the complement system and plays an important role in the innate immune system. mbl replacement in mbl-deficient children with chemotherapy-induced neutropenia represents a new approach to lower the risk of febrile episodes, of hospital admission, of prolonged use of intravenous antibiotics and of severe infections. the aim of the phase ii study is to find evidence for the correct prediction of plasma levels of mbl necessary for clinical effects and biological efficacy, to confirm the dosage regimen needed to reach the required mbl plasma levels, and reconfirm the safety and lack of side-effects.

Eligibility criteria:
inclusion criteria: * children ages 0 - 12 years, during chemotherapy, and expected to become neutropenic * mbl deficiency by genotype or phenotype (\< 100 ng/ml) * informed consent and assent of patient and/or legal representative exclusion criteria: * inability or unwillingness to comply with the protocol or likely inability to complete the study period * known allergic reactions to mbl and other human plasma products * participation in other investigational drug studies within the last month * clinically relevant abnormalities in: serum immunoglobulins igg, iga, igm; blood counts; complement factors measured by ap50, ch50; urine protein and cell counts; serum creatinine and liver enzymes, as routinely determined for regular patient care.

Keywords: mbl-deficient chemotherapy neutropenia chemotherapy-induced neutropenia
first in human study for pf-06667272

Conditions: Healthy

Summary: the current study is the first clinical trial proposed with pf-06667272. it is designed to evaluate the safety, tolerability, and pharmacokinetics (pk) of single ascending doses of pf-06667272 under fed and fasted conditions, in healthy adult subjects.


Eligibility criteria:
inclusion criteria: * healthy males and female of non-childbearing potential; * body mass index 17.5-30.5 kg/m2; * body weight \>50 kg; exclusion criteria: * evidence of history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing)
bladder outlet obstruction observation using dynamic urine vibration "holter"

Conditions: Bladder Outlet Obstruction

Summary: current gold standard of bladder outlet diagnosis is pressure flow study. this study is invasive time consuming and requires expensive and complex set-up. in this study the investigators plan to evaluate an alternative technology that presumably is able to diagnose bladder outlet obstruction using a dynamic urine vibration "holter" based on a urine flow vibration analysis technology. the acoustic vibration sensor is a small device that records the vibration due to urine flow. the patient attaches the sensor to the penis using a disposable sensor patch for the duration of approximately one minute during one urination. the analysis is performed off-line and the results are compared to the results of a standard pressure flow study and to the standard free flowmetry test. the innovative technology for the diagnosis of bladder outlet obstruction is noninvasive, rapid and does not involve complex setup.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of benign prostatic hyperplasia (bph) * has indication for urodynamic evaluation * males 18 years and older * capability of understanding and having signed the informed consent form after full discussion of the research, nature of the treatment, and its risks and benefits. exclusion criteria: any condition which, in the investigator opinion, makes the patient unsuitable

Keywords: benign prostatic hyperplasia (bph) acoustic vibration
biologic augmented repair of complex anal fistula using acellular matrix and/or autologous platelet-rich plasma

Conditions: Anal Fistula

Summary: the purpose of this study is to compare the clinical effectiveness of augmenting surgical repair of complex anal fistula using autologous prp and/or micronized acellular porcine urinary bladder matrix (ubm) to usual surgical care alone to prevent fistula recurrence or improve hrqol, to compare the effects of augmenting surgical repair of complex anal fistula using autologous prp and/or micronized acellular porcine urinary bladder matrix on early postoperative pain and fecal continence and to assess the cost utility of augmented complex fistula repair relative to usual surgical care


Eligibility criteria:
inclusion criteria: * complex cryptoglandular transsphincteric anal fistula undergoing surgical repair by lift or advancement flap procedure * english or spanish speaking and capable of providing informed consent * willing to undergo temporary anal seton drainage for requisite time prior to repair * participating surgeons will only be eligible if they perform at least 3 repair procedures/year exclusion criteria: * unable to reliably complete follow up for 12 months postoperatively * primary platelet disorders * thrombocytopenia \< 150 plt/microliter * inability to stop anti-platelet agent \> 5 days preoperatively * fistula associated with inflammatory bowel disease (ibd), malignancy or pelvic/perineal radiation
xparts ii: capecitabine/cddp(xp) and s-1/cddp(sp) as the first-line treatment for advanced gastric cancer

Conditions: Gastric Cancer

Summary: the aim of this study is to elucidate the efficacy and safety of xp and sp for first-line treatment of advanced gastric cancer.

xp and sp are either standard treatment for advanced gastric cancer. the aim of this study is to elucidate the efficacy and safety of capecitabine/cisplatin and s-1/cisplatin for first-line treatment of advanced gastric cancer.

Eligibility criteria:
inclusion criteria: 1. histologically confirmed gastric adenocarcinoma with unresectable metastatic or recurrent disease 2. lesions confirmed on imaging within 28 days before registration (not required measurable lesions as defined in recist version 1.1) 3. no previous chemotherapy or radiotherapy. however, adjuvant chemotherapy is allowed the case of more than 6 months from the end of adjuvant chemotherapy 4. ecog performance status of 0 to 2 5. life expectancy of at least 3 months after registration 6. written informed consent 7. age of 20 to 74 years with either gender 8. adequate major organ functions within 14 days before registration exclusion criteria: 1. positive her2 status 2. previous history of fluoropyrimidines therapy within 6 months prior to registration 3. previous treatment with platinum agents 4. previous history of serious hypersensitivity to fluoropyrimidines or platinum agents 5. previous history of adverse reactions suggestive of dihydropyrimidine dehydrogenase (dpd) deficiency 6. more than one cancer at the same time or more than one cancer at different times separated by a 5-year disease-free interval. however, multiple active cancers do not include carcinoma in situ or skin cancer which is determined to have been cured as a result of treatment. 7. obvious infection or inflammation (pyrexia ≥ 38.0˚c) 8. active hepatitis 9. heart disease that is serious or requires hospitalization, or history of such disease within past year 10. having complication that is serious or requires hospitalization (intestinal paralysis, intestinal obstruction, interstitial pneumonia or pulmonary fibrosis, poorly controlled diabetes mellitus, renal failure, liver disorders, or hepatic cirrhosis) 11. being treated or in need of treatment with flucytosine, phenytoin or warfarin potassium 12. chronic diarrhea (watery stool or ≥4 times/day) 13. active gastrointestinal bleeding 14. body cavity fluids requiring drainage or other treatment 15. clinical suspicion or previous history of metastasis to brain or meninges 16. women who are pregnant, breastfeeding, or potentially (hoping to become) pregnant 17. unwillingness to practice contraception 18. poor oral intake 19. psychiatric disorders which are being or may need to be treated with psychotropics 20. otherwise determined by investigators or site principal investigators to be unsuitable for participation in study

Keywords: unresectable gastric cancer recurrent gastric cancer stageiv gastric cancer adenocarcinoma of the stomach xp sp
comparison of two doses of edoxaban using different tests (assays) and clinical outcomes

Conditions: Atrial Fibrillation

Summary: atrial fibrillation is when the heart's two upper chambers (called atria) beat chaotically and irregularly, out of coordination with the two lower chambers (called ventricles) of the heart. this can lead to blood clots forming in the heart chamber. patients with atrial fibrillation will be treated with either 60 mg or 75 mg of edoxaban for up to 12 months, with a 2-4 week follow-up, after which their participation is complete. blood samples will be collected before the first dose of study drug (day 0), and on days 30, 90 and 360 (at pre dose, 1-2 hours post dose and 4-8 hours post-dose).


Eligibility criteria:
inclusion criteria: * meets protocol-specified criteria for qualification * is able to follow the protocol specified contraception methods * is willing and able to comply with any restrictions related to food, drink and medications * voluntarily consents to participate and provides written informed consent prior to any protocol-specific procedures exclusion criteria: * has history or current use of over-the-counter medications, dietary supplements, or drugs (including nicotine and alcohol) outside protocol-specified parameters * has signs, symptoms or history of any condition that, per protocol or in the opinion of the investigator, might compromise: 1. the safety or well-being of the participant or study staff 2. the safety or well-being of the participant's offspring (such as through pregnancy or breast-feeding) 3. the analysis of results

Keywords: nonvalvular atrial fibrillation high creatinine clearance developmental phase iii anticoagulant naïve